Betapace: Advanced Rhythm Control for Atrial Fibrillation
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Synonyms | |||
Betapace (sotalol hydrochloride) is a class III antiarrhythmic agent specifically formulated for the management of life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation or atrial flutter. As a non-cardioselective beta-adrenergic blocker with additional potassium channel blocking properties, it offers a dual mechanism of action that distinguishes it from simpler rate-control agents. Its use requires careful patient selection, initiation in a monitored setting due to proarrhythmic potential, and ongoing evaluation of renal function and QT interval. This comprehensive profile details the pharmacological characteristics, clinical applications, and essential safety information healthcare providers must consider when prescribing Betapace.
Features
- Active ingredient: Sotalol hydrochloride
- Available in 80 mg, 120 mg, 160 mg, and 240 mg tablet strengths
- Dual antiarrhythmic properties: beta-adrenergic blockade (Class II) and potassium channel blockade (Class III)
- Renal elimination with half-life of approximately 12 hours in normal renal function
- Requires hospital initiation with continuous ECG monitoring for at least 3 days
- Black Box Warning regarding life-threatening ventricular arrhythmias, particularly torsades de pointes
Benefits
- Provides effective conversion and maintenance of sinus rhythm in atrial fibrillation/flutter
- Reduces ventricular rate during arrhythmia episodes through beta-blockade
- Offers single-agent therapy for patients requiring both rhythm and rate control
- Demonstrates predictable pharmacokinetics with twice-daily dosing in appropriate patients
- May reduce symptom burden and improve quality of life in properly selected patients
- Established safety profile when administered with appropriate monitoring and patient selection
Common use
Betapace is primarily indicated for the maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation or atrial flutter who are currently in sinus rhythm. It is also approved for the treatment of documented life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. The medication is particularly valuable in patients who require both rhythm control and ventricular rate reduction during arrhythmia episodes. Clinical use requires careful consideration of the patient’s renal function, cardiac status, and risk factors for proarrhythmia. Betapace is not recommended as first-line therapy for atrial fibrillation except in specific clinical circumstances where its dual mechanisms provide particular advantage.
Dosage and direction
Dosage must be individualized based on renal function, QT interval response, and clinical efficacy. For atrial fibrillation/flutter, the initial dose is typically 80 mg twice daily, which may be increased after 3 days (after adequate monitoring) to 120 mg twice daily if the QT interval remains <500 ms. The maximum recommended dose is 160 mg twice daily. For ventricular arrhythmias, initial dosing ranges from 80 mg twice daily to 160 mg twice daily based on clinical judgment. All patients must be initiated on Betapace in a facility capable of continuous ECG monitoring, calculating creatinine clearance, and managing serious arrhythmias. Dosage adjustment is required in renal impairment, with extended dosing intervals recommended for creatinine clearance below 60 mL/min.
Precautions
Betapace requires careful patient selection and ongoing monitoring. Baseline assessment must include electrolyte levels (potassium and magnesium), renal function, and ECG with QTc measurement. Hypokalemia and hypomagnesemia must be corrected before initiation. Patients should be monitored for excessive bradycardia, particularly those taking other negative chronotropic agents. Caution is warranted in patients with heart failure, asthma, chronic obstructive pulmonary disease, diabetes, and thyroid disorders. Periodic monitoring of renal function is essential, as dosage adjustments are required with declining renal function. Patients should be advised to avoid dehydration and to report symptoms such as dizziness, palpitations, or syncope promptly.
Contraindications
Betapace is contraindicated in patients with baseline QT interval greater than 450 msec, severe sinus node dysfunction, second- or third-degree AV block without a functioning pacemaker, congenital long QT syndrome, cardiogenic shock, uncontrolled heart failure, hypotension, bronchial asthma, and severe chronic obstructive pulmonary disease. Additional contraindications include creatinine clearance less than 40 mL/min, hypersensitivity to sotalol, and metabolic acidosis. The medication should not be used in combination with other QT-prolonging drugs or in circumstances where bradycardia would be poorly tolerated.
Possible side effect
Common side effects include fatigue (10-20%), dizziness (10-15%), bradycardia (10-15%), dyspnea (10-12%), and chest pain (5-10%). Proarrhythmic events may occur in 4-5% of patients, with torsades de pointes representing the most serious risk. Other cardiovascular effects may include hypotension, heart failure exacerbation, and palpitations. Non-cardiovascular side effects can include nausea, vomiting, diarrhea, insomnia, depression, and visual disturbances. Most side effects are dose-related and may diminish with time or dosage adjustment. However, any suggestion of proarrhythmia requires immediate medical evaluation.
Drug interaction
Betapace has numerous significant drug interactions. Concomitant use with other QT-prolonging agents (antiarrhythmics, antipsychotics, antibiotics) increases torsades de pointes risk. Calcium channel blockers and digoxin may exacerbate bradycardia and conduction abnormalities. Insulin and oral hypoglycemics may mask hypoglycemia symptoms. Beta-2 agonists may have reduced effectiveness. Drugs that affect renal function may alter sotalol elimination. CYP450 interactions are minimal as sotalol is not metabolized hepatically. A comprehensive medication review is essential before initiation and during therapy.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next dose. Patients should never double the dose to make up for a missed dose. Consistent timing of administration is important to maintain stable drug levels. If multiple doses are missed, medical advice should be sought as re-initiation may require monitoring, particularly if more than 48 hours have passed since the last dose.
Overdose
Sotalol overdose may manifest as excessive bradycardia, hypotension, heart failure, bronchospasm, hypoglycemia, and life-threatening ventricular arrhythmias including torsades de pointes. Management includes gastric lavage if presentation is early, followed by activated charcoal. Supportive care includes ECG monitoring, electrolyte correction, and management of specific manifestations. Bradycardia may respond to atropine, isoproterenol, or cardiac pacing. Hypotension may require fluids and vasopressors. Torsades de pointes is managed with magnesium sulfate, pacing, or isoproterenol. Hemodialysis may be effective due to sotalol’s renal elimination.
Storage
Store at room temperature (15-30°C or 59-86°F) in a tight, light-resistant container. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Protect from moisture and excessive heat. Proper disposal of unused medication is recommended through take-back programs or following FDA-recommended disposal methods if no program is available.
Disclaimer
This information is intended for healthcare professionals and should not replace professional medical advice, diagnosis, or treatment. Betapace is a prescription medication that requires careful patient selection, initiation under monitored conditions, and ongoing supervision. The prescribing physician must be thoroughly familiar with the drug’s risks, benefits, and monitoring requirements. Patients should be fully educated about the signs and symptoms requiring immediate medical attention. Always refer to the full prescribing information before initiating therapy.
Reviews
Clinical studies demonstrate Betapace’s efficacy in maintaining sinus rhythm, with approximately 50-60% of patients remaining in sinus rhythm at one year compared to 30-40% with placebo. The SWORD trial highlighted the importance of appropriate patient selection, as patients with recent myocardial infarction and reduced ejection fraction showed increased mortality. More recent studies confirm its value in selected patient populations when properly monitored. Many electrophysiologists appreciate its dual mechanism of action and predictable pharmacokinetics, though all emphasize the critical importance of careful patient selection and monitoring. Patient-reported outcomes generally show improved quality of life when sinus rhythm is maintained, though side effects particularly fatigue and bradycardia may limit tolerability in some individuals.